Application 202871
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | TABLET;ORAL | 25MG | No | No |
| 002 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | TABLET;ORAL | 50MG | No | No |
| 003 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8421 | METOPROLOL TARTRATE | METOPROLOL | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8422 | METOPROLOL TARTRATE | METOPROLOL | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8423 | METOPROLOL TARTRATE | METOPROLOL | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0904-6340 | Metoprolol Tartrate | Metoprolol Tartrate | Major Pharmaceuticals | ANDA | Current |
| 0904-6340 | Metoprolol Tartrate | Metoprolol Tartrate | Major Pharmaceuticals | ANDA | Current |
| 0904-6341 | Metoprolol Tartrate | Metoprolol Tartrate | Major Pharmaceuticals | ANDA | Current |
| 0904-6341 | Metoprolol Tartrate | Metoprolol Tartrate | Major Pharmaceuticals | ANDA | Current |
| 0904-6342 | Metoprolol Tartrate | Metoprolol Tartrate | Major Pharmaceuticals | ANDA | Current |
| 0904-6342 | Metoprolol Tartrate | Metoprolol Tartrate | Major Pharmaceuticals | ANDA | Current |
| 46708-112 | Metoprolol Tartrate | Metoprolol Tartrate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-113 | Metoprolol Tartrate | Metoprolol Tartrate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-114 | Metoprolol Tartrate | Metoprolol Tartrate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-290 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-291 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-292 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Limited | ANDA | Current |
| 53808-1076 | Metoprolol Tartrate | Metoprolol Tartrate | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-6894 | Metoprolol Tartrate | Metoprolol Tartrate | Cardinal Health | ANDA | Current |
| 55154-6894 | Metoprolol Tartrate | Metoprolol Tartrate | Cardinal Health | ANDA | Current |
| 55154-6895 | Metoprolol Tartrate | Metoprolol Tartrate | Cardinal Health | ANDA | Current |
| 55154-6895 | Metoprolol Tartrate | Metoprolol Tartrate | Cardinal Health | ANDA | Current |
| 55154-7626 | Metoprolol Tartrate | Metoprolol Tartrate | Cardinal Health | ANDA | Current |
| 55154-7626 | Metoprolol Tartrate | Metoprolol Tartrate | Cardinal Health | ANDA | Current |
| 62332-112 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-112 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-112 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-113 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-113 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-113 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-114 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-114 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-114 | METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 68151-4645 | Metoprolol Tartrate | Metoprolol Tartrate | Carilion Materials Management | ANDA | Current |
| 70518-3506 | METOPROLOL TARTRATE | METOPROLOL | REMEDYREPACK INC. | ANDA | Current |
| 71205-003 | METOPROLOL TARTRATE | METOPROLOL | Proficient Rx LP | ANDA | Current |
| 71205-003 | METOPROLOL TARTRATE | METOPROLOL | Proficient Rx LP | ANDA | Current |
| 71335-0666 | METOPROLOL TARTRATE | METOPROLOL | Bryant Ranch Prepack | ANDA | Current |